Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External FixatorPinsidesNCT03842956
Wound Closure (Allgower) Versus Secondary Open Wound Healing After Removal of the External Fixator
A study testing Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe in people with Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
In this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after Fixator-Extern is removed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator
- What is being tested?
- Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completed 18th year of age
- Supply by external fixator
- Signed informed consent for study participation
Who cannot join
- Patients with immunodeficiency (HIV / hepatitis infection, leukemia, steroid therapy, autoimmune therapy)
- Patients who can not perform a follow-up treatment for structural reasons (tourists, not home canton) or other reasons
- Lack of knowledge of German
- Lack of consent to study participation
- invalid patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Wound Closure (Allgower) Versus Secondary Open Wound Healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial"
In this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after Fixator-Extern is removed. Although this topic embodies a daily business, there is no standard to be found in literature regarding the treatment of pin sites with closure by either primary or secondary intent.
Read the detailed description
In the orthopedic department of the Kantonsspital Lucerne (LUKS) after removal of the external fixator, the pin sites at the tibia and the back of the foot are routinely treated with primary wound closure. An international survey carried out by the LUKS shows that in comparison to our standard treatment the majority of surgeons left the pin sites open during the healing process. In order to find a standardized method to treat pin sites we conduct a randomized controlled trial, in which half of the pin site wounds are left open and the other half are treated by primary wound closure after local debridement (Treatment of the first pin-side will be randomized, then alternated treatment of the consecutive pin-sides). All patients of the study participants are treated within a fixed pre- and postoperative protocol, which includes antibiotic prophylaxis with a single shot of Cefazolin 2g intravenously 30 minutes prior to surgery. The postoperative pin care includes daily inspection of the pin sites, cleaning the secondary healing wound with Ringerfundin © and disinfection with Betadine ©. Primary wound closures are dressed with dry gaze bandage. The following out-patient treatment is provided either by a Spitex support, the family doctor or by the patient himself, depending on the patients compliance. Regular follow-up consultations at 2, 6, 12, 24 and 52 weeks after surgery ensure an adequate surveillance of the healing process, whereas the examining doctor at the second and last consultation was kept in dark what therapy was chosen for pin sites of the patient. To objectify the clinical progress the pin sites are photo documented at the consultations at week 2 and 52.
- Being tested
- Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe
- Keywords
- Fixator extern, Fixateur externe, External fixator, Wound healing, Fix-Ex, Pin Side, Trauma, Infection
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externeProcedure or surgery
We compare the outcome of primary wound closure (Allgower) and secondary open wound healing by comparing infection-rates, use of antibiotics, reoperation-rates, satisfaction of the patients and optical results using the Vancouver scar scale
| Study group | Role | What they receive |
|---|---|---|
| Primary wound healing | Active comparator | Primary woundclosure in Allgöwer suture technique Receives: Procedure: Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe |
| Secondary wound healing | No intervention | no closure, open wound healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post surgical pin side wound infections according to center of disease control (CDC)
Measured: up to 12 weeks after surgery
Secondary outcomes (4)
Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection
Measured: up to 52 weeks after surgery
Time to wound healing of the pin sides
Definition wound healing: complete epithelialization
Measured: up to 6 weeks after surgery
Vancouver scar scale
ExercisingPigmentation 0-2, Vascularity 0-3, Pliability 0-5, Height 0-3, so that the score has got a total score reaching from 0 up to 13
Measured: up to 52 weeks after surgery
subjective perception of the wounds
questionnaire on subjective preference of the patient
Measured: up to 52 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jan 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External FixatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reto Babst, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842956
- Sponsor's protocol ID
- 2018-01316
- Other IDs
- 2018
- Acronym
- Pinsides
- Status last verified
- Aug 2022
- First submitted
- 8 Feb 2019
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tillmann F, Hoepelman RJ, Cagienard F, Link BC, Babst R, van de Wall BJM, Beeres FJP. Primary Closure or Secondary Wound Healing of Pin Sites After External Fixator Removal: A Single-Center Blinded Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):207-213. doi: 10.2106/JBJS.22.00234. Epub 2023 Jan 9.
PubMed 36622896Roth F, Cagienard F, Link BC, Hodel S, Lehnick D, Babst R, Beeres FJP. Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial. Trials. 2020 Feb 19;21(1):205. doi: 10.1186/s13063-020-4087-8.
PubMed 32075685
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Wound Closure (Allgower) Versus Secondary Open Wound Healing of the Pin Sites After Removal of the External Fixator: Study Protocol for a Prospective, Randomized Controlled Mono-center Trial"
- ClinicalTrials.gov ID
- NCT03842956
- Acronym / sponsor ID
- Pinsides / 2018-01316
- Keywords
- Fixator extern, Fixateur externe, External fixator, Wound healing, Fix-Ex, Pin Side, Trauma, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective randomized controlled single-center trial, based on a non-inferiority design, the outcome of the treatment of patients are analyzed, whereas in half of the cases the wounds are left open and the other ones are primary wound closed after local debridement after Fixator-Extern is removed. Although this topic embodies a daily business, there is no standard to be found in literature regarding the treatment of pin sites with closure by either primary or secondary intent.
Detailed description
In the orthopedic department of the Kantonsspital Lucerne (LUKS) after removal of the external fixator, the pin sites at the tibia and the back of the foot are routinely treated with primary wound closure. An international survey carried out by the LUKS shows that in comparison to our standard treatment the majority of surgeons left the pin sites open during the healing process. In order to find a standardized method to treat pin sites we conduct a randomized controlled trial, in which half of the pin site wounds are left open and the other half are treated by primary wound closure after local debridement (Treatment of the first pin-side will be randomized, then alternated treatment of the consecutive pin-sides). All patients of the study participants are treated within a fixed pre- and postoperative protocol, which includes antibiotic prophylaxis with a single shot of Cefazolin 2g intravenously 30 minutes prior to surgery. The postoperative pin care includes daily inspection of the pin sites, cleaning the secondary healing wound with Ringerfundin © and disinfection with Betadine ©. Primary wound closures are dressed with dry gaze bandage. The following out-patient treatment is provided either by a Spitex support, the family doctor or by the patient himself, depending on the patients compliance. Regular follow-up consultations at 2, 6, 12, 24 and 52 weeks after surgery ensure an adequate surveillance of the healing process, whereas the examining doctor at the second and last consultation was kept in dark what therapy was chosen for pin sites of the patient. To objectify the clinical progress the pin sites are photo documented at the consultations at week 2 and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary wound healing | Active comparator | Procedure: Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externePrimary woundclosure in Allgöwer suture technique |
| Secondary wound healing | No intervention | –no closure, open wound healing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Completed 18th year of age
- Supply by external fixator
- Signed informed consent for study participation
Key exclusion criteria (5 listed)
- Patients with immunodeficiency (HIV / hepatitis infection, leukemia, steroid therapy, autoimmune therapy)
- Patients who can not perform a follow-up treatment for structural reasons (tourists, not home canton) or other reasons
- Lack of knowledge of German
- Lack of consent to study participation
- invalid patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externeWe compare the outcome of primary wound closure (Allgower) and secondary open wound healing by comparing infection-rates, use of antibiotics, reoperation-rates, satisfaction of the patients and optical results using the Vancouver scar scale | Procedure or surgery | Primary wound healing |
Primary outcome
Post surgical pin side wound infections according to center of disease control (CDC)
Time frame: up to 12 weeks after surgery
4 secondary outcomes
Surgical wound revision of the pin sides, carried out antibiotic therapy in a wound infection
Time frame: up to 52 weeks after surgery
Time to wound healing of the pin sides
Time frame: up to 6 weeks after surgery
Vancouver scar scale
Time frame: up to 52 weeks after surgery
subjective perception of the wounds
Time frame: up to 52 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 36622896Tillmann F, Hoepelman RJ, Cagienard F, Link BC, Babst R, van de Wall BJM, Beeres FJP. Primary Closure or Secondary Wound Healing of Pin Sites After External Fixator Removal: A Single-Center Blinded Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):207-213. doi: 10.2106/JBJS.22.00234. Epub 2023 Jan 9.
- Derived from this study: PubMed 32075685Roth F, Cagienard F, Link BC, Hodel S, Lehnick D, Babst R, Beeres FJP. Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial. Trials. 2020 Feb 19;21(1):205. doi: 10.1186/s13063-020-4087-8.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe in people with Infection Rates Between Primary Wound-closure (Allgower) and Secondary Wound Healing After Removal of an External Fixator, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post surgical pin side wound infections according to center of disease control (CDC) (time frame: up to 12 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.